The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Mobile Operating Table For Orl Microsurgery.
Device ID | K853720 |
510k Number | K853720 |
Device Name: | MOBILE OPERATING TABLE FOR ORL MICROSURGERY |
Classification | Table, Operating-room, Electrical |
Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
Contact | Marie Pederson |
Correspondent | Marie Pederson CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
Product Code | GDC |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-05 |
Decision Date | 1985-10-18 |